FDA 510(k), K210444, EZ-Injec LDV Sterile Safety Needle
FDA 510(k), K210444, EZ-Injec LDV Sterile Safety Needle
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510(K) Number: K210444
Device Name: EZ-Injec LDV Sterile Safety Needle
Manufacturer: Poonglim Pharmatech Inc.
Device Classification Name: low dead space needle, single lumen, hypodermic
Regulation Number: 880.5570
Classification Product Code: QNS
Date Received: 02/16/2021
Decision Date: 02/16/2021
Regulation Medical Specialty: General Hospital
Device Name: EZ-Injec LDV Sterile Safety Needle
Manufacturer: Poonglim Pharmatech Inc.
Device Classification Name: low dead space needle, single lumen, hypodermic
Regulation Number: 880.5570
Classification Product Code: QNS
Date Received: 02/16/2021
Decision Date: 02/16/2021
Regulation Medical Specialty: General Hospital
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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